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Last Updated: April 15, 2026

Details for New Drug Application (NDA): 210169


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NDA 210169 describes VALGANCICLOVIR HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Granules, Hetero Labs Ltd V, MSN, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Pharmobedient, Somerset Theraps Llc, Sph Zhongxi Pharm, and Strides Pharma Intl, and is included in seventeen NDAs. It is available from nineteen suppliers. Additional details are available on the VALGANCICLOVIR HYDROCHLORIDE profile page.

The generic ingredient in VALGANCICLOVIR HYDROCHLORIDE is valganciclovir hydrochloride. There are seventeen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
Summary for 210169
Tradename:VALGANCICLOVIR HYDROCHLORIDE
Applicant:Msn
Ingredient:valganciclovir hydrochloride
Patents:0
Pharmacology for NDA: 210169
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 210169
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride FOR SOLUTION;ORAL 210169 ANDA MAJOR PHARMACEUTICALS 0904-7419 0904-7419-04 1 BOTTLE in 1 CARTON (0904-7419-04) / 100 mL in 1 BOTTLE
VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride FOR SOLUTION;ORAL 210169 ANDA airis PHARMA PVT LTD 71151-003 71151-003-01 100 mL in 1 BOTTLE, DISPENSING (71151-003-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength50MG/ML
Approval Date:Feb 17, 2022TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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